PRESERVATION I: Bioabsorbable Cardiac Matrix Shows No Effect on Preventing Cardiac Remodeling
Bioabsorbable Cardia Matrix (BCM) injected into the coronary artery during percutaneous coronary intervention (PCI) had no significant effect on preventing cardiac remodeling compared to a saline placebo, according to results of the PRESERVATION I trial presented Sept. 1 during ESC Congress 2015 in London.
The study randomized 303 patients from Australia, Belgium, Canada, France, Germany, Israel, Poland Spain and the U.S. to receive an intracoronary injection of BCM or saline. The primary endpoint was a change from baseline in left ventricular end diastolic volume index (LVEDVI). Results found no significant difference in LVEDVI between the two groups, as well as no significant differences in serious adverse events.
Lead investigator Uwe Zeymer, MD, from Ludwigshafen, Germany, said the results were "somewhat surprising and disappointing" given previous encouraging results in experimental studies and pilot trial in humans. "We had expected to find a reduction in left ventricular enlargement and an improvement in clinical symptoms compared to saline control," he said.
Moving forward, Zeymer notes that further studies are necessary to "determine the optimal timing and target population for this innovative therapy."
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